A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

Inclusion Criteria:

- Subjects 30-90 years of age at the time of Informed Consent

- Subjects with type 1 or type 2 Diabetes Mellitus with a non-healing, full-thickness,
University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot
ulcers

- Subjects who have an ulcer with a duration of at least 4 weeks, but not greater than
52 weeks at time of screening

- Subjects with an index ulcer measuring between 1 - 10 cm2 in area after debridement
(Area = length x width)

- Subjects with a diabetic foot ulcer(s) at or below the malleoli

- Subjects who demonstrates adequate arterial perfusion defined as either:

- transcutaneous oxygen measurements of the dorsum of the foot > 30 mm Hg with a
skin perfusion pressure > 30 mm Hg, or an ankle/brachial index (ABI) above 0.7,
with documented confirmation of adequate arterial perfusion, or

- a Doppler waveform consistent with adequate flow in the foot (biphasic or
triphasic waveforms) at screening, or

- absolute toe pressure of > 30 mm Hg

- Subject and/or caregiver must be able and willing to learn and perform the duties of
dressing changes

- Subjects are able and willing to comply with standardized off-loading regimen (such
as a fixed ankle walker)

Exclusion Criteria:

- Subjects < 30 or > 90 years of age at the time of Informed Consent

- Subjects with Target Ulcers with a duration < 4 weeks or > 52 weeks

- Subjects with ulcers measuring less than 1 cm2 or greater than 10 cm2 in area
(Area = length x width) after debridement at the time of screening

- Subjects whose ulcer decreased in area by > 30 % during the 1 week screening
period

- Subjects with evidence of gangrene on any part of affected limb

- Subjects with active Charcot's foot on the study limb

- Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis at
the time of enrollment

- Subjects with active infection at the time of screening

- Subjects with a target ulcer which has exposed tendons, ligaments, muscle, or
bone

- Subjects with active malignancy, excluding non-melanoma skin cancer

- Subjects with a history of malignancy on study limb

- Subjects in whom oral, or IV antibiotic/antimicrobial agents or medications have
been used within 2 days (48 hours) of baseline

- Subjects who are currently receiving or has received radiation or chemotherapy
within 3 months of randomization

- Subjects who have received growth factor therapy (e.g., autologous platelet-rich
plasma gel, becaplermin, bilayered cell therapy, dermal substitute,
extracellular matrix) within two weeks of screening

- Subjects who are pregnant at the time of screening

- Subjects who are undergoing active renal dialysis

- Subjects who have a known immune insufficiency, excluding Diabetes Mellitus

- Subjects with a history of peripheral vascular repair within 14 days of
screening

- Subjects with a current deep vein thrombosis (DVT)

- Subjects with ulcers due to Raynaud's disease

- Subjects with and ulcer due to acute thrombophlebitis

- Subjects with inadequate perfusion to support healing

- Subjects with necrotic wounds covered with eschar or slough

- Subjects with wounds with fistulae or deep sinus tracts of unknown depth

- Subjects who are receiving palliative care

- Subjects who have a HbA1c > 12% (uncontrolled hyperglycemia)

- Subjects whose target ulcer has a known etiology of: malignancy, burn, collagen
vascular disease, sickle cell, vasculopathy, or pyoderma gangrenosum

- Subjects with a documented history of alcohol or substance abuse within 6 months
of screening

- Subjects who are currently enrolled or who have participated, within 30 days of
screening, in another investigational device, drug or biological trial that may
interfere with study results

- Subjects with a known allergy to dressing materials, including occlusive
dressings and the adhesives on such dressings